Catalog Number 1012452-15 |
Device Problems
Break (1069); Difficult To Position (1467)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/24/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Internal file number - (b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: (b)(4).Visual, dimensional and functional inspections were performed on the returned device.The reported difficulty to position was confirmed.Additionally, an inner member separation was noted at the proximal balloon marker.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported difficulty.
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Event Description
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It was reported that the procedure was to treat a lesion located in the non-tortuous, but heavily calcified right coronary artery.The 3.75 x 15 mm nc trek could not be advanced on the guide wire.Another 3.75 x 15 mm nc trek was able to advance on the same guide wire without issue and was used successfully.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.Return device analysis revealed the inner member was separated; however, the outer member was still intact.
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Manufacturer Narrative
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(b)(4).On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues.Abbott vascular performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The root cause identification was complicated by the fact that users were describing multiple symptoms when reporting the complaints.To date, the frequency of worldwide reported events for difficulties removing the protective balloon sheath, inflation and deflation has reached an actionable limit, thus abbott vascular communicated the voluntary field action to the fda [medwatch # 2024168-2017-02310].Corrective action has been implemented per site operating procedures.The product will continue to be trended.The abbott internal recall number is 2024168-3/14/2017-002-r.
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Search Alerts/Recalls
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